Job Description
Book-in, full data entry, narrative writing/I-Narrative, medical coding, product coding, self-check of online QC tool, un-blinding (if required), case routing, case lock/closure where applicable, and labeling including USPI labeling.
Quality check of fatal & reliable cases, to keep daily track of quality metrics of the case-processing defects, communication of quality metrics to case processing associates and discussion about steps taken to correct the errors, ensure the quality of the deliverable is as expected
Supervise day-to-day operations of a team of Case Processing Associates/QR Associates; allocate case inventory and manage workflow distribution.
Monitor individual and team productivity, quality, and TAT/SLA metrics; conduct periodic case audits and provide coaching/feedback.
Handle escalations for complex or ambiguous cases; support un-blinding and case lock/closure decisions where required.
Support onboarding and training of new associates; conduct calibration sessions to align on coding/narrative standards.
Manage multiple sub-teams (through Team Leaders) responsible for case processing, medical coding, and quality review across the project.
Own end-to-end delivery metrics (quality, TAT, volume) for the assigned scope; drive corrective and preventive actions (CAPA) for recurring defects.
Ensure adherence to SOPs, regulatory timelines, and audit/inspection readiness.
Must have Skill Set
Pharmacovigilance Case Processing
Labeling Expertise
Narrative Writing
Quality Review
Regulatory Knowledge
Safety Databases
📌 PV-Case Processing (Hyderabad)
🏢 Golden Opportunities
📍 Hyderabad
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